Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2023 Publisher: Sandoz Limited, Park View, Riverside Way, Watchmoor Park, Camberley, Surrey, GU15 3YL, United Kingdom
Treatment of primary hypercholesterolaemia or mixed dyslipidaemia, as an adjunct to diet, when response to diet and other non-pharmacological treatments (e.g. exercise, weight reduction) is inadequate.
Treatment of homozygous familial hypercholesterolaemia (HoFH) as an adjunct to diet and other lipid-lowering treatments (e.g. LDL apheresis) or if such treatments are not appropriate.
Reduction of cardiovascular mortality and morbidity in patients with manifest atherosclerotic cardiovascular disease or diabetes mellitus, with either normal or increased cholesterol levels, as an adjunct to correction of other risk factors and other cardioprotective therapy (see section 5.1).
The dose range is 5-80 mg/day of simvastatin given orally as a single dose in the evening. Adjustments of dose, if required, should be made at intervals of not less than 4 weeks, to a maximum of 80 mg/day given as a single dose in the evening. The 80 mg dose is only recommended in patients with severe hypercholesterolaemia and at high risk for cardiovascular complications who have not achieved their treatment goals on lower doses and when the benefits are expected to outweigh the potential risks (see sections 4.4 and 5.1).
The patient should be placed on a standard cholesterol-lowering diet, and should continue on this diet during treatment with simvastatin. The usual starting dose is 10-20 mg/day given as a single dose in the evening. Patients who require a large reduction in LDL-C (more than 45%) may be started at 20-40 mg/day given as a single dose in the evening. Adjustments of dose, if required, should be made as specified above.
Based on the results of a controlled clinical study, the recommended starting dose is simvastatin 40 mg/day in the evening. Simvastatin should be used as an adjunct to other lipid-lowering treatments (e.g. LDL apheresis) in these patients or if such treatments are unavailable.
In patients taking lomitapide concomitantly with simvastatin, the dose of simvastatin must not exceed 40 mg/day (see sections 4.3, 4.4 and 4.5).
The usual dose of simvastatin is 20 to 40 mg/day given as a single dose in the evening in patients at high risk of coronary heart disease (CHD, with or without hyperlipidaemia). Medicinal product therapy can be initiated simultaneously with diet and exercise. Adjustments of dose, if required, should be made as specified above.
Simvastatin is effective alone or in combination with bile acid sequestrants. Dosing should occur either >2 hours before or >4 hours after administration of a bile acid sequestrant.
In patients taking simvastatin concomitantly with fibrates, other than gemfibrozil (see section 4.3) or fenofibrate, the dose of simvastatin should not exceed 10 mg/day. In patients taking amiodarone, amlodipine, verapamil, diltiazem, or products containing elbasvir or grazoprevir concomitantly with simvastatin, the dose of simvastatin should not exceed 20 mg/day. (see sections 4.4 and 4.5).
No modification of dose should be necessary in patients with moderate renal impairment.
In patients with severe renal impairment (creatinine clearance <30 ml/min), doses above 10 mg/day should be carefully considered and, if deemed necessary, implemented cautiously.
No dose adjustment is necessary.
For children and adolescents (boys Tanner Stage II and above and girls who are at least one year post-menarche, 10–years of age) with heterozygous familial hypercholesterolaemia, the recommended usual starting dose is 10 mg once a day in the evening. Children and adolescents should be placed on a standard cholesterol-lowering diet before simvastatin treatment initiation; this diet should be continued during simvastatin treatment.
The recommended dosing range is 10–40 mg/day; the maximum recommended dose is 40 mg/day. Doses should be individualised according to the recommended goal of therapy as recommended by the paediatric treatment recommendations (see sections 4.4 and 5.1). Adjustments should be made at intervals of 4 weeks or more. The experience of simvastatin in pre-pubertal children is limited.
Simvastatin is for oral administration. Simvastatin can be administered as a single dose in the evening.
To date, a few cases of overdose have been reported; the maximum dose taken was 3.6 g. All patients recovered without sequelae. There is no specific treatment in the event of overdose. In this case, symptomatic and supportive measures should be adopted.
Blisters: 3 years.
Tablet containers: 3 years.
Blister:
Do not store above 30°C.
Keep the blisters in the outer carton, in order to protect from light.
Tablet container:
Do not store above 30°C.
Store in the original container, in order to protect from light.
Blister (Al/PVC).
Pack sizes: 10, 20, 28, 30, 40, 49, 50, 50 × 1, 60, 84, 90, 98 and 100 film-coated tablets.
Polyethylene tablet container with screw cap.
Pack sizes: 10, 20, 28, 30, 40, 50, 84, 90, 100, 120 and 250 film-coated tablets.
Not all pack sizes or pack types may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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